A wearable cardioverter defibrillator with a low false alarm rate.

INTRODUCTION: A wearable cardioverter defibrillator (WCD) is indicated in appropriate patients to reduce the risk for sudden cardiac death. Challenges for patients wearing a WCD have been frequent false shock alarms primarily due to electrocardiogram noise and wear discomfort. The objective of this study was to test a contemporary WCD designed for reduced false shock alarms and improved comfort. METHODS: One hundred and thirty patients with left ventricular ejection fraction ≤40% and an active implantable cardioverter defibrillator (ICD) were fitted with the ASSURE WCD (Kestra Medical Technologies) and followed for 30 days. WCD detection was enabled and shock alarm markers recorded, but shocks and shock alarms were disabled. All WCD episodes and ICD ventricular tachycardia/ventricular fibrillation (VT/VF) episodes were adjudicated. The primary endpoint was the false-positive shock alarm rate with a performance goal of 1 every 3.4 days (0.29 per patient-day). RESULTS: Of 163 WCD episodes, 4 were VT/VF and 159 non-VT/VF (121 rhythms with noise, 32 uncertain with noise, 6 atrial flutter without noise). Only three false-positive shock alarm markers were recorded; one false-positive shock alarm every 1333 patient-days (0.00075 per patient-day, 95% confidence interval: 0.00015-0.00361; p < .001). No ICD recorded VT/VF episodes meeting WCD detection criteria (≥170 bpm for ≥20 s) were missed by the WCD during 3501 patient-days of use. Median wear was 31.0 days (interquartile range [IQR] 2.0) and median daily use 23.0 h (IQR 1.7). Adverse events were mostly mild: skin irritation (19.4%) and musculoskeletal discomfort (8.5%). CONCLUSION: The ASSURE WCD demonstrated a low false-positive shock alarm rate, low patient-reported discomfort, and no serious adverse events.

Real-world comparison of in-hospital Reveal LINQ insertable cardiac monitor insertion inside and outside of the cardiac catheterization or electrophysiology laboratory.

BACKGROUND: Traditionally, insertable cardiac monitor (ICM) procedures have been performed in the cardiac catheterization (CATH) or electrophysiology (EP) laboratory. The introduction of the miniaturized Reveal LINQ ICM has led to simplified and less invasive procedures, affording hospitals flexibility in planning where these procedures occur without compromising patient safety or outcomes. METHODS: The present analysis of the ongoing, prospective, observational, multicenter Reveal LINQ Registry sought to provide real-world feasibility and safety data regarding the ICM procedure performed in the CATH/EP lab or operating room and to compare it with insertions performed outside of these traditional hospital settings. Patients included had at least a 30-day period after the procedure to account for any adverse events. RESULTS: We analyzed 1222 patients (58.1% male, age 61.0 ± 17.1 years) enrolled at 18 centers in the US, 17 centers in Middle East/Asia, and 15 centers in Europe. Patients were categorized into 2 cohorts according to the location of the procedure: in-lab (CATH lab, EP lab, or operating room) (n = 820, 67.1%) and out-of-lab (n = 402, 32.9%). Several differences were observed regarding baseline and procedure characteristics. However, no significant differences in the occurrence of procedure-related adverse events (AEs) were found; of 19 ICM/procedure-related AEs reported in 17 patients (1.4%), 11 occurred in the in-lab group (1.3%) and 6 in the out-of-lab group (1.5%) (P = .80). CONCLUSIONS: This real-world analysis demonstrates the feasibility of performing Reveal LINQ ICM insertion procedures outside of the traditional hospital settings without increasing the risk of infection or other adverse events.

Real-World Use of Prophylactic Antibiotics in Insertable Cardiac Monitor Procedures.

BACKGROUND: The use of prophylactic antibiotics during insertable cardiac monitor (ICM) procedures is a carryover of the common practice used with therapeutic cardiac implantable electronic devices. We sought to characterize the current practice of ICM insertion procedures to evaluate the influence of prophylactic antibiotic administration on the occurrence of infections. METHODS: We characterized insertion procedures and procedure-related infections from an ongoing multicenter registry (Reveal LINQ(TM) Registry). In order to accurately capture infections, only patients enrolled before or the day of insertion who also had a record of whether or not preoperative antibiotics were used were included in this analysis. Infections were defined based on the physician's assessment and reported upon occurrence. Patients were categorized into two analysis cohorts based on prophylactic antibiotic use. RESULTS: We analyzed 375 patients from 14 U.S. centers (age 63.1 ± 15.6 years; male 54.1%). Approximately two-thirds of patients (66.4%) did not receive any preprocedural antibiotics. The overall infection rate was 1.1% (0.3-2.7% confidence interval [CI]) and corresponded to four events. In the group that did not receive preprocedural antibiotics, there were two minor infections (0.8%, [0.1-2.9% CI]), whereas in the group receiving preprocedural antibiotics a serious and a minor infection occurred (1.6%, [0.2-5.6% CI]); this serious infection resulted in an explant. CONCLUSIONS: Current real-world practice shows that ICM insertions are increasingly performed without the use of prophylactic antibiotics, which is associated with a very low infection rate.

Management of Neurogenic Orthostatic Hypotension in Neurodegenerative Disorders: A Collaboration Between Cardiology and Neurology.

Treatment of patients with α-synucleinopathies (e.g., Parkinson disease, multiple system atrophy, diffuse Lewy body disease) may require clinicians to manage both neurologic and cardiovascular issues due to autonomic dysfunction. In addition to the underlying neurodegenerative condition, patients often experience blood pressure dysregulation, such as neurogenic orthostatic hypotension (nOH) and/or supine hypertension. This commentary details the collaborative care between a cardiologist and neurologist to effectively manage medically complex patients with nOH by illustrating the case of a 76-year-old man with a history of multiple system atrophy who experienced recurrent syncope when standing or sitting and falls with loss of consciousness. The patient could walk only a few steps before experiencing a substantial drop in systolic blood pressure (100 mmHg). He also had features of profound parkinsonism (e.g., tremor, facial masking) that required treatment with levodopa, but orthostatic symptoms related to the blood pressure drop needed improvement first. The neurologist and cardiologist collaborated to diagnose nOH and initiate droxidopa treatment, which led to resolution of syncope, control of orthostatic symptoms, and improvement of orthostatic blood pressure. Considerations in the collaborative care of patients with nOH are outlined, including screening protocols, treatment goals and options, mitigation of supine hypertension risk (a condition that frequently coexists with nOH), and management of other comorbidities. In conclusion, collaboration between neurologists and cardiologists is an efficient method to improve outcomes for patients with nOH because this care model allows specialist providers to leverage their areas of expertise to manage the wide spectrum of clinical features associated with nOH. Further, communication and cooperation of the patient care team can lead to reduced patient morbidity, optimal relief of nOH symptoms, improvements in activities of daily living and quality of life, and decreased caregiver burden. Management of Neurogenic Orthostatic Hypotension in Neurodegenerative Disorders: A Collaboration Between Cardiology and Neurology (MP4 73511 kb).

People with nervous system disorders such as Parkinson disease, multiple system atrophy, or diffuse Lewy body dementia often experience neurogenic orthostatic hypotension (nOH). nOH occurs when blood pressure becomes too low when a person stands up after lying down or sitting, which can cause weakness, loss of consciousness, and falls. Other common symptoms of nOH include lightheadedness, fainting/feeling faint, trouble thinking clearly, pain in the neck and shoulders ("coat hanger" pain), and feeling tired. People with nOH are at risk of incurring injuries from a fall. A neurologist or cardiologist can identify if a person has nOH by asking about symptoms and measuring the person's blood pressure when lying down and after standing. They may also ask the patient to keep a diary of blood pressure measurements taken at home. When a patient's neurologist and cardiologist work together as a team, they can ensure that nOH is treated safely and effectively, and patients may find their nOH symptoms are better managed. nOH can be treated with lifestyle changes such as drinking more water, eating more salty food, or gentle exercises. If needed, healthcare providers can prescribe medications to treat nOH.

Long-term cost effectiveness of early and sustained dual oral antiplatelet therapy with clopidogrel given for up to one year after percutaneous coronary intervention results: from the Clopidogrel for the Reduction of Events During Observation (CREDO) trial.

OBJECTIVES: This study sought to evaluate the long-term cost effectiveness of a clopidogrel loading strategy before percutaneous coronary intervention (PCI) followed by continued treatment for one year. BACKGROUND: The Clopidogrel for the Reduction of Events During Observation (CREDO) trial, a randomized trial of 2,116 patients, showed the effectiveness of antiplatelet therapy with clopidogrel 300 mg before PCI and 75 mg daily for one year afterward compared with placebo load and placebo days 29 to 365 in reducing the combined risk of death, myocardial infarction, and stroke. All patients received clopidogrel on days 1 to 28 and aspirin on days 1 to 365. METHODS: All hospitalizations were assigned a diagnosis-related group. Associated costs were estimated three ways (including professional costs): 1) Medicare costs, 2) MEDSTAT costs, and 3) blend with Medicare for those age > or = 65 years and MEDSTAT for those age <65 years. Clopidogrel 75 mg cost 3.22 dollars. Life expectancy in trial survivors was estimated using external data. Confidence intervals were assessed by bootstrap. RESULTS: The primary composite end point occurred in 89 (8.45%) clopidogrel patients and in 122 (11.48%) placebo patients (relative risk reduction [RRR] 26.9%; 95% confidence interval [CI] 3.9% to 44.4%). The number of life-years gained (LYG) with clopidogrel was 0.1526 (95% CI 0.0263 to 0.2838) using Framingham data and 0.1920 (95% CI 0.054 to 0.337) using Saskatchewan data. Average total costs were 664 dollars higher for the clopidogrel arm (95% CI -461 dollars to 1,784 dollars). The incremental cost-effectiveness ratios (ICERs) based on Framingham data ranged from 3,685 dollars/LYG to 4,353 dollars/LYG, with over 97% of bootstrap-derived ICER estimates below 50,000 dollars/LYG. The ICERs based on Saskatchewan data were 2,929 dollars/LYG to 3,460 dollars/LYG, with over 98% of estimates below 50,000 dollars/LYG. CONCLUSIONS: Platelet inhibition with clopidogrel loading before PCI followed by therapy for one year is highly cost effective.

Impact of angina burden and other factors on treatment satisfaction after acute coronary syndromes.

PURPOSE: Although of great importance to clinicians, hospitals, and health care systems, little is known about factors that influence treatment satisfaction after acute coronary syndromes (ACS). The objective of this study was to identify potentially modifiable factors associated with treatment satisfaction 7 months after ACS. METHODS: The study population included 1957 patients with ACS who were enrolled in the multicenter, prospective Veterans' Health Administration Access to Cardiology Study. The primary outcome was treatment satisfaction 7 months after ACS as measured by the Seattle Angina Questionnaire. Multivariable regression models were developed to determine the association between treatment satisfaction and patient characteristics, physician-patient communication, and current angina frequency. RESULTS: Patient characteristics associated with reduced treatment satisfaction included a history of depression, atrial fibrillation, prior heart surgery, arthritis, hypertension, younger age, and a discharge diagnosis of unstable angina (as opposed to myocardial infarction). After adjusting for patient characteristics, patient-reported inability to reach one or more of their physicians (OR, 2.40; 95% CI, 1.47 to 3.91), being given confusing information (OR, 3.48; 95% CI, 2.08 to 5.83), and poor overall communication with one or more of their physicians (OR, 4.94; 95% CI, 2.93 to 8.34) were all associated with reduced satisfaction. Finally, after adjustment for both patient characteristics and physician communication, weekly (OR, 3.52; 95% CI, 2.28 to 5.45) and daily angina (OR, 3.88; 95% CI, 2.23 to 6.75) were associated with worse treatment satisfaction. CONCLUSIONS: Current angina symptoms and aspects of physician communication are independently associated with treatment satisfaction after ACS. These results suggest that treatment satisfaction may be improved through better communication and better control of angina symptoms.